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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Showing 14,441–14,460 of 17,974 drug recalls
Drug RecallTerminatedHistorical recordClass II
Albuterol Sulfate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.
Albendazole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.
Adenosine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.
Acetazolamide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.
2-Methoxyestradiol active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.
2-Deoxy-D-Glucose active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, On
by Attix Pharmaceuticals
Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.
4-Aminopyridine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.
Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01), barcode (01)00351801004019, packaged in 100-count strips per carton (NDC 51801-004-40, UPC 3 51801 00440 8), Nomax, Inc., St. Louis, MO 63123 USA.
by Nomax Inc
Reason
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips.
Recall initiated
March 24, 2015
Reported by FDA
April 29, 2015
Distribution
Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesville, OH 43701
by Cardinal Health
Reason
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
by Apotex Inc.
Reason
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 in, NDC: 52544-044-80, C) Haelan Tape (Fludroxycortide), Bulk Rolls, NDC: 55515-014-00.
by Actavis Laboratories
Reason
Subpotent Drug: Flurandrenolide is subpotent.
Recall initiated
April 14, 2015
Reported by FDA
April 22, 2015
Distribution
U.S. Nationwide, including Puerto Rico; United Kingdom.
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
by Baxter Healthcare Corp
Reason
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
by Central Admixture Pharmacy Services, Inc.
Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
by Central Admixture Pharmacy Services, Inc.
Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
by Central Admixture Pharmacy Services, Inc.
Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
by Central Admixture Pharmacy Services, Inc.
Reason
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
